483
Zhuhai United Laboratories Co. Ltd.FDA 483 - Zhuhai United Laboratories Co. Ltd. - July 16, 2019
Record Details
This FDA Form 483 was issued to Zhuhai United Laboratories Co., Ltd. in Zhuhai, China, a manufacturer of sterile and non-sterile APIs and finished drugs. The inspection revealed significant deficiencies in quality control, laboratory procedures, data integrity, and environmental monitoring, particularly concerning out-of-specification investigations and data management. These issues indicate a lack of robust controls to ensure the quality and sterility of drug products.
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ID · 530097df-5ce0-4ee1-9d58-9e0e17fe9cf7